Jarvik Heart won Japanese regulatory approval for its left ventricular assist device, bringing its heart pump rivalry with Thoratec to Asia. Japan's Pharmaceuticals and Medicines Devices Agency signed off on the Jarvik 2000 Heart based on Japanese and U.S. clinical trial data, approving it as a bridge to transplant.
FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.
Medtronic announced Thursday it has approval in the EU and Australia to market its new system for renal denervation to treat uncontrolled hypertension.
Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.
Tyrx won FDA clearance to expand the use of its next-generation antibacterial envelope for spinal cord neuromodulator implants. In doing so, it is staking claim to an infection control market with a product line that has few, if any, competitors.
It looks like BioDelivery Sciences is on its way to a Phase III clinical trial of its topical gel treatment for painful diabetic neuropathy following a "positive" meeting with the FDA.
When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.
Endoscopic device maker Xlumena has CE Mark approval in the EU for its AXIOS gastrointestinal stent and delivery system--but the endoscopic devices haven't yet cleared the FDA for sale in the U.S. To that end, the company has secured a fresh infusion of capital--$25 million.
Every time the FDA has discussed compounding pharmacies and the need to keep fake drugs out of the supply chain in recent years, one message has shone through--we need more power. Now, the FDA is being given some, but not all, of the powers it wants, and has begun to discuss how it plans to use its new authority.